Host Genetic Susceptibility to Avian Influenza A/H5N1

This study has been completed.
Sponsor:
Collaborators:
University of Oxford
Wellcome Trust
Information provided by:
South East Asia Infectious Disease Clinical Research Network
ClinicalTrials.gov Identifier:
NCT01074736
First received: February 23, 2010
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

The identification and characterization of susceptibility loci for H5N1 infection in humans could have profound implications. The detection of host genetic factors may shed light on key pathogenic interactions between H5N1 and human cells, assisting in identifying the viral characteristics determining pandemic potential. In addition, the identification and verification of susceptibility loci would be followed by functional studies which might point the way to new therapeutic and preventive options.

The objective of this study is to investigate if host genetic factors are associated with susceptibility to influenza H5N1 illness


Condition
Influenza A Virus/H5N1 Subtype

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Host Genetic Susceptibility to Avian Influenza A/H5N1 in Vietnam, Thailand, Indonesia and Singapore

Resource links provided by NLM:


Further study details as provided by South East Asia Infectious Disease Clinical Research Network:

Biospecimen Retention:   Samples With DNA
  • whole blood in tubes containing EDTA
  • mouth wash.
  • buffy coat; cell pellet from centrifuged blood, nucleic acid extracted for diagnostic purposes, serum, throat, nose or endotracheal swabs

Enrollment: 500
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This is primarily an hypothesis screening exercise and while guesses based on biological plausibility are possible, a comprehensive analysis of genetic susceptibility can only be achieved by a whole genome approach. Therefore we will test for genetic linkage and association using a large number of Single Nucleotide Polymorphisms (SNPs) spanning the whole genome.

Principal Investigators have access to information on all surviving and deceased laboratory confirmed H5N1 cases. These cases will form the study base. The epidemiologist will attempt to make telephone contact with either the recovered patient or,if the patient died, the closest relative of the deceased patient. The proposed study will be explained and permission will be sought for the epidemiologist and a study nurse to visit the household to explain the study in greater detail, to offer an opportunity for questions and, if the subject agrees, to obtain informed consent for participation. If the epidemiologist has difficulty in making contact with the case or their family the local public authorities will be asked to assist in making contact. Eligible family members of H5N1 cases will be identified by face-to-face interviews with the surviving confirmed cases or close family members of deceased cases.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • symptomatic cases with laboratory confirmed H5N1 infection will be eligible for inclusion.
  • Priority for recruitment will be given to cases from multi-case families in order tomaximize the probability of including cases with a genetic etiology.
Criteria

Inclusion Criteria:

  • The individual had a clinically compatible illness (defined as respiratory symptoms and an abnormal chest x-ray or encephalitis), AND
  • Influenza A/H5 RNA identified in a clinical sample by reverse transcription-polymerase chain reaction [RT-PCR], OR
  • Influenza A/H5 cultured from a clinical sample, OR
  • High titres (1:80 or higher) of anti-H5 antibodies by microneutralization in convalescent samples of patients who had a compatible illness but no or negative RT-PCR, AND
  • The patient survived or if they died an archived biological specimen is available for potential DNA extraction, AND
  • Valid, written consent is obtained.
  • The biological parents and biological siblings of all the cases and any other family members linking two cases, AND
  • Valid, written consent is obtained.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074736

Locations
Vietnam
Oxford University Clinical Research Unit
Hanoi, Vietnam
Sponsors and Collaborators
South East Asia Infectious Disease Clinical Research Network
University of Oxford
Wellcome Trust
Investigators
Principal Investigator: Tawee Chotpitayasunond, Professor Queen Sirikit National Institute of Child Health, Bangkok, Thailand
Principal Investigator: Herawati Sudoyo, Dr. Eijkman Institute for Molecular Biology, Jakarta, Indonesia
Principal Investigator: Tran Hien Nguyen, Professor National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
Principal Investigator: Martin Hibberd, Dr. Genome Institute of Singapore, Singapore
  More Information

Publications:

Responsible Party: Peter Horby, NCC Oxford University Clinical Research Unit - The Hospital for Tropical Diseases, Vietnam
ClinicalTrials.gov Identifier: NCT01074736     History of Changes
Other Study ID Numbers: SEA 007
Study First Received: February 23, 2010
Last Updated: November 3, 2010
Health Authority: Indonesia: Departement Kesehatan (Department of Health)
Thailand: Ethical Committee
Singapore: Domain Specific Review Boards
United Kingdom: Research Ethics Committee
Vietnam: Ministry of Health

Keywords provided by South East Asia Infectious Disease Clinical Research Network:
influenza A/H5N1
host genetic susceptibility
genotyping

Additional relevant MeSH terms:
Influenza, Human
Disease Susceptibility
Influenza in Birds
Genetic Predisposition to Disease
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014